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Design Prospective double-blinded randomized control trial.
Study Period 1/7/2022 - 30/6/2024 for case recruitment.
Suitable patient will be recruited. Informed consent will be signed. Objective smell assessment will be done using the University of Pennsylvania Smell Identification Test (UPSIT) and Butanol Threshold Test (BTT). Subjective quality of life score will be obtained by Sino-Nasal Outcome Test (SNOT-22). Subjective smell and taste assessment will be assessed by Visual Analogue Scale (VAS). Patient will be randomized into treatment group and control group using computer generated list by an independent nursing staff. Doctors and the patients will be blinded during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Olfactory training by neurological chemosensory stimulation using aromatic substances delivered via diffusers. Four aromatic substances will be used. Each substance will be given for 20 seconds sequentially, providing a total of 80 seconds of olfactory stimulation three times per day for 3 months. |
|
| Control arm | Placebo Comparator | Same diffuser will be given to control group. All of the four essential oils will be replaced by normal saline using the same packing. Same treatment regime of 20 seconds for each diffuser three times per day for 3 months will be instructed to control group patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olfactory Training | Other | Four aromatic substances will be used (Citrus limon, Eucalyptus radiata, Pelargonium graveolens, Juniperus virginiana) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Olfactory threshold changes after olfactory training after 3 months | Parameter: Olfactory threshold using Butanol Threshold Test (BTT) | 3 months after starting smell training |
| Olfactory identification score changes after olfactory training after 3 months | Parameter: Olfactory identification using Smell Identification Test (UPSIT) | 3 months after starting smell training |
| Quality of life changes after olfactory training after 3 months | Parameter: Subjective quality of life score using Sino-Nasal Outcome Test (SNOT-22) | 3 months after starting smell training |
| Taste and smell changes after olfactory training after 3 months | Parameter: Subjective smell and taste assessment using Visual Analogue Scale (VAS) | 3 months after starting smell training |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Chuen Fergus Wong, FRCSEd(ORL) | Contact | 64600771 | wkc568@ha.org.hk | |
| Ka Chung Kwan, FRCSEd(ORL) | Contact | 64600056 |
| Name | Affiliation | Role |
|---|---|---|
| Kai Chuen Fergus Wong, FRCSEd(ORL) | Pamela Youde Nethersole Eastern Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamela Youde Nethersole Eastern Hospital | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000094562 | Olfactory Training |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Randomly assigned by computer into treatment group and control group
| Control | Other | Normal Saline will be used |
|
| D013568 | Pathological Conditions, Signs and Symptoms |